Down and Out in MA – The PTO Denies The Medicines Company’s Request for Reconsideration for ANGIOMAX Patent Term Extension

Massachusetts-based The Medicines Company (“TMC”) has lost its latest battle with the U.S. Patent and Trademark Office (“PTO”) for a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), a drug product FDA first approved late on Friday, December 15, 2000 under New Drug Application (“NDA”) 20-873. The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity that will expire on September 23, 2010, when generic competition is anticipated (notwithstanding the recent addition of two new patents to the Orange Book for ANGIOMAX). As we previously reported, TMC submitted a PTE application to the PTO 62 days after FDA approved the company’s ANGIOMAX NDA. Under 35 U.S.C. § 156(d)(1), the submission of a PTE application must occur “within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval). In March 2002, and again in April 2007, the PTO denied the PTE request as untimely. Since then, TMC has agressively – and thus far unsuccessfully – sought a PTE for the ‘404 patent at the PTO and on Capitol Hill (see our previous posts here, here, and here).

As we recently reported, in December 2009, TMC submitted a Petition and a Request for Reconsideration of its PTE application to the PTO. The Petition requested that the PTO suspend its regulations at 37 C.F.R. § 1.750 “to the extent they limit requests for reconsideration of patent term extension applications to a single submission within the times specified in the rule.” TMC previously requested reconsideration of the PTO’s denial of a PTE for the ‘404 patent on the basis that the date of approval of the ANGIOMAX NDA was in fact first effective as of Monday, December 18, 2000, the next business day after the December 15, 2000 NDA approval.

The Request for Reconsideration requested the PTO to employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period at 35 U.S.C. § 156(d)(1) to commence on the first business day after the day the FDA transmits notice of NDA approval of the drug product if that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on December 18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1).

Among other things, TMC argued that its Request for Reconsideration is “particularly appropriate in this case” given the PTO’s “newly announced approach to counting days under § 156(d)(1).” The PTO, after being challenged as to the date on which the 60-day period at 35 U.S.C. § 156(d)(1) begins, ruled in the context of another PTE application that although the PTO had in some instances started counting the 60-day period on the date after NDA approval, “[b]y not counting the date of FDA approval as one of the sixty days included in the time period for filing a PTE application, the USPTO was failing to comply with section 156 and case law.”

The USPTO is persuaded by Applicant's argument for suspension of Rule 750 under the terms of Rule 183. That latter regulation states: "In an extraordinary situation, when justice requires, any requirement of the regulations in this part which is not a requirement of the statutes may be suspended or waived by the Director or the Director's designee, sua sponte, or on petition of the interested party, subject to such other requirements as may be imposed." 37 C.F.R. § 1.183. Since the USPTO has corrected its methodology of counting the time period of 35 U.S.C. § 156(d)(1) to conform with the express language of the statute and first applied its corrected counting methodology in finally denying Applicant's PTE application, the USPTO finds that justice favors giving Applicant the opportunity to address the denial of its PTE application under the USPTO new counting methodology. Accordingly, Applicant's petition filed under Rule 183 to suspend Rule 750 is GRANTED. [(italics and emphasis in original)]

However, TMC ultimately lost when the PTO denied the company’s Request for Reconsideration:

Applicant raises numerous arguments why the USPTO should consider its PTE application for the ' 404 patent based on the regulatory review period for Angiomax® (bivalirudin) timely filed under section 156(d)(1). Distilling those arguments to their core, Applicant asserts that the 60-day time window of section 156(d)(I) should not commence until an applicant can "be deemed to be on notice" of the FDA approval. Request for Reconsideration at 11. Because the USPTO finds that the section 156(d)(1) expressly sets forth the trigger date for compliance with section 156(d)(1) as the date the applicant may commercially market or use the approved product, which is the date of NDA approval, and does not take an applicant's receipt of such notice into consideration, the USPTO considers Applicant's arguments to be unpersuasive. The present request for reconsideration of the denial of the PTE application for the '404 patent therefore is DENIED. [(emphasis in original)]

TMC’s latest loss at the PTO is unlikely to be the last we hear from the company on this topic. A lawsuit against the PTO is not out of the question. And although TMC’s efforts to lobby Congress to pass legislation that would amend 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application for the ‘404 patent have not yet been fruitful, we understand that a deal is in the works (or at least was until the Massachusetts election on Tuesday) to include a provision in the Health Care Bill that would extend the '404 patent.